ISO 13485 quality system Implementation

ISO 13485 quality system Implementation

Alacramed was asked to assist in putting an ISO 13485:2016 Quality System in place.

Our client is an innovative, young and rapidly growing company that is applying its proprietary technology to the development of non-regulated medical products. It has seen an opportunity to develop and market regulated medical device and IVD products using the same technology and has realised that it needs to put an appropriate quality system in place before embarking on this new strategy. An internal project team has been set up to do this, but it is finding it difficult to gain traction within the company, to undertake what is a substantial amount of work in parallel with ‘business as normal.’ Our client asked Alacramed to review its implementation project plan and to provide long-term guidance and input to the project at the level of several days a month over initially a one-year period.

Medical device regulatory consulting

We are a specialist medical device consultancy consisting of industry experts with long and successful track records in commercialising medical device products. We have broad functional and sector experience, and would welcome an opportunity to discuss with you any challenge relating to creating sustainable value from medical technologies.